Observed

The process for making mobile health apps is different than creating traditional mobile apps. In addition, governing bodies like the FDA regulate some types of healthcare apps.

These Software as a Medical Device (or SaMD) apps require a more detailed process and additional steps. In this blog post, we’ll discuss the different types of healthcare apps and some unique characteristics of healthcare mobile app development.

A mobile phone, a sphygmomanometer, and a notebook.

What is a Medical Mobile App?

A medical mobile app is a type of software application designed for medical practitioners and patients with a variety of medical needs. These apps typically feature tools and resources for monitoring health and diagnosing medical conditions, as well as for managing medical prescriptions and appointments. They may also include features for communicating with medical professionals or accessing other medical information, such as patient records or medical research studies.

The popularity of medical mobile apps has grown rapidly in recent years due to their convenience, flexibility, and ability to help connect patients with the care they need at any time and from anywhere. The true potential utility of health apps in the healthcare industry is in its infancy.

There are two main types: those used by healthcare professionals and those used by patients. Healthcare professional-facing apps include things like electronic health records, diagnostic tools, and reference materials. Patient-facing medical apps include things like fitness trackers, medication reminders, and disease management programs.

A mobile phone next to a laptop and stethoscope.

Can an App be a Medical Device?

The FDA defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article” intended for diagnosis, prevention, or treatment of a disease. This definition includes things like pacemakers and x-ray machines.

This definition also includes app-based medical devices, also known as Software as a Medical Devices (SaMD). However, this is where it gets tricky, not every healthcare app is considered a SaMD.

What is the Difference Between a Medical App and a SaMD?

The FDA provides guidance (with examples) on apps NOT considered medical devices.

A regular healthcare app primarily provides information to patients to stay informed, track behavioral data, and make decisions about their health. 

A SaMD, on the other hand, is intended for use as an active treatment or diagnosis tool. In order to be considered a SaMD, the app must provide accurate, actionable information.

A stethoscope sitting on a table.

What are the Different Classes of Medical devices?

In the United States, medical devices are classified into three categories: Class I, II, and III. The requirements for regulatory approval vary depending on the class.

Class I devices are considered low risk and include things like tongue depressors and bandages. These low-risk devices are subject only to general controls, the lowest level of regulatory control.

Class II devices are considered medium risk and include things like blood pressure cuffs and pregnancy test kits. Class II devices must follow the same general controls as class I, but also have special requirements such as performance standards and postmarket surveillance. 

For example, a 510(k) submission is required for FDA clearance to legally market these products. If not done correctly this can be costly in time and money.

The devices falling into Class III, or “high risk” categories, pose an increased risk to patients. These can be life-supporting tools like machines and monitors used in hospitals (or private homes), pacemakers, and implantable defibrillators. 

To retain market access within the US, these medical innovations must go through rigorous approval processes called Premarket Approval (PMA). Before products ship to shelves or app stores, PMA ensures compliance with all federal regulations.

What are examples of medical apps?

There are many different types of medical apps available. Some examples include fitness trackers, medication reminders, and disease management programs.

When developing a healthcare app, you must know the difference between a regular app and a SaMD. You’ll also need to determine which class your app falls into and follow the appropriate development process. 

There are many benefits to developing a medical app, but you must do your research and create a quality product to reduce the risks that come along with developing a SaMD app.

Below are examples of class I to III medical apps as well as non-regulated apps for informational use. In reality, determining the class of your app is an important early phase in your project. This should involve a number of qualified experts who can help evaluate the intended use of your app.

Screenshots from Spot On, a birth control and period tracking mobile app.

Non-regulated Healthcare App Examples

We’ve developed a number of applications in the healthcare app space, and we’re particularly proud of our work with Planned Parenthood on Spot On, a birth control and period tracker. Other examples include fitness apps, healthcare dictionaries, medication reminders, and communication portals.

Class I Examples

This is the most common classification of SaMD. One example makes measurements to estimate visual acuity. An app leveraging machine vision to estimate the angles of joints to facilitate physical therapy would likely fall in this classification.

Class II Examples

Apps in this classification are often used in conjunction with a physical counterpart. They often measure and analyze data to inform diagnosis or treatment. The Medly for Heart Failure app is a class II example that facilitates self-management for patients suffering from heart failure.

Class III Examples

It is rare to find mobile applications in this classification that typically support or sustain human life. Software in this class is more commonly in a medical device, for example in an automated defibrillator.

Illustration of a developer at a computer

What is the Process to Develop a Medical App?

The first step in developing a medical app is determining which category your app falls into. Class I and II devices have less stringent requirements, while Class III devices require more extensive testing and approval from the FDA.

Once you’ve determined the class of your device, you can begin developing your app. However, there are additional steps SaMDs require.

SaMD development first requires a risk analysis. This will help you develop a plan for mitigating any issues. You should also create user testing plans and validate your app’s accuracy and functionality. Once your app is complete, you’ll submit it to the FDA for review and approval.

What are the Benefits of Developing a Medical App?

Developing a medical app can have many benefits. Medical apps can improve patient outcomes by providing them with access to accurate and up-to-date information. They can also help reduce healthcare costs by making it easier for patients to self-manage their conditions. 

In addition, medical apps can help improve communication between patients and their healthcare providers.

Mobile applications are an intimate extension of your brand. Your users literally hold it in their hands and interact with it in now commonplace ways. Whether your application is a necessary part of a healthcare process, or a useful but optional adjunct, ensuring its usability is paramount.

Unlike in other app contexts, there is less expectation of sparking joy in the user. However, their positive experience will increase the likelihood of use by them and others. This will lead to increased benefits for more patients and will reflect positively on your brand.

What are the Risks of Developing a Medical App?

There are many benefits to developing a medical app, but there are also some risks. One of the biggest risks? Your app may not meet regulatory requirements, and could be pulled from the market (or subjected to expensive fines). In addition, patients or healthcare professionals could give your app a less-than-ideal reception.

How long does it take to build a medical app?

The development timeline for a medical app will vary depending on the class of your app and the regulatory requirements. Class I and II devices have less stringent requirements, while Class III devices require more extensive testing and approval from the FDA. {years longer — check notes from BI}

hurdle, barrier, obstacle

Unique challenges with healthcare app development

Developing software for use as a medical device (SaMD) involves special considerations. These apps are subject to regulation by governing bodies such as the FDA. In addition to classifying your app, performing risk analyses, and other regulatory requirements, there are some additional concerns unique to medical app development.

Privacy

Privacy is one of the most important considerations when creating a mobile health application. Medical professionals and patients must be confident their personal information is secure and confidential. In order to achieve this goal, proper privacy practices are essential from the onset of development. 

This may involve adhering to HIPAA standards for data protection in the US, as well as taking other steps such as implementing encryption technology and enabling user privacy settings.

Give careful thought to how the app will interact with other healthcare systems, as this can also affect privacy for both patients and providers. Privacy should never be an afterthought and should be incorporated into every step of healthcare app design.

Security

When handling patient data, it’s important extra precautions are taken to ensure the data is secure. Only authorized personnel may access the data, and all data must be encrypted. In addition, you’ll need to create a plan for how you will handle patient data in the event of a breach.

An illustration of a user and a wireframe representation of a user interface on a mobile phone.

User Experience

The user experience of any app should always be a priority, but this applies even more so with healthcare apps. A positive user experience builds trust and encourages long-term use of apps. A solid user experience will prevent confusion while using an app, and reflects well on your brand.

First and foremost, it’s important to understand the needs of both doctors and patients. What information do they need to be able to access? How can the app make the tasks easier and safer? It’s also important to consider things like navigation and screen layout. How easy is it for users to find what they’re looking for? Is the information clear and concise? 

These are just some of the questions you’ll face. By taking UX factors into account, you can develop a user-friendly and successful app.

Abstract illustration of a brain representing artificial intelligence.

Use of Artificial Intelligence

Medical applications increasingly rely on artificial intelligence (AI) and machine learning to provide better patient care. The recent surges of progress in AI and machine learning are some of the most exciting and promising advancements in the industry. Their application in medicine and healthcare has enormous potential.

AI can help develop predictive models that can identify patients at risk for certain conditions, such as diabetes or heart disease. AI can also help create personalized treatment plans based on a patient’s individual medical history and health condition. 

Additionally, AI could monitor a patient’s health over time, providing real-time feedback on progress. In this way, AI could potentially transform medical care by making it more personalized, more effective, and more efficient.

From a regulatory perspective, the FDA has provided guidance on the use of artificial intelligence in SaMD. However, AI is still in its early stages of development. A tremendous amount of research is required to fully realize its potential.

Bulletin board filled with note cards of various colors.

Recommendations for how to make a medical app

If we can make one recommendation it is to take your time. The process for approval for a regulated health app is substantially longer than a traditional app. It is best to take more time at the start of the project to clearly define and understand the needs of the app users, as well as the intended use of the application.

Dedicating time and resources early in the project, and performing user and market research, are investments that will reveal hidden requirements and improve the likelihood your application will meet those requirements and resonate with users.

Rushing the process also increases the chances of a healthcare app’s rejection during the approval process. This results in far greater delays than dedicating adequate preparation time early in the development lifecycle.

More than with traditional apps, to develop a healthcare app we need to leverage experts in the field. No two apps are the same, so the requirements will vary, but inputs from

Conclusions

Developing a healthcare mobile app can be a great way to improve patient outcomes and reduce healthcare costs. However, some risks are associated with their development. It’s important to do your research to create an amazing product and reduce those risks.

If you’re thinking about developing a medical app, Small Planet can help. We have experience in developing both traditional and SaMDs.

Contact us to learn more about how we can help you create a quality product that meets all regulatory requirements.